NCT02160184已完成不适用
Nocturnal Insulin-Glucose in Hospital: Tight Control
Corporacion Parc Tauli2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.
研究概览
简要总结
The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes
- •Diabetes duration > 3 years
- •Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year
- •No ketoacidosis during the previous 12 months
- •Glomerular Filtration Rate (GFR) > 60 ml/kg/min m2
- •Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice
排除标准
- •Gastroparesis
- •Hypoglycemia unawareness
- •Uncorrected visual impairment
- •BMI> 35 kg/m2
结局指标
主要结局
Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.
时间窗: During the closed-loop period for each patient: 12 hours
次要结局
未报告次要终点
研究者
Mercedes Rigla
MD, PhD
Corporacion Parc Tauli
研究点 (2)
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